The Effect of Topical Lidocaine on Pain Scores During Manual Vacuum Aspiration for Nonviable Pregnancies

July 18, 2016 updated by: Amanda Tower, Bridgeport Hospital

When a patient requires a manual vacuum aspiration (MVA), whether for an undesired pregnancy, missed abortion, or other nonviable pregnancy, she is undergoing an emotional experience. She is grieving the loss of her pregnancy, and is then faced with the anxiety of an invasive and often painful procedure. Minimizing the pain during this procedure must not be overlooked. There have been no randomized controlled trials evaluating pain control during MVA for nonviable pregnancy, and the data is mixed regarding analgesia for MVA for an elective abortion or other office procedures.

Women being treated at the Women & Infants Triage who have experienced a first trimester missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy and are being treated with an outpatient manual vacuum aspiration will be asked to enroll in this study. Those who wish to participate will be randomly assigned to treatment with lidocaine gel or a placebo gel applied to the cervix during their procedure.

The hypothesis is that topical lidocaine will decrease pain during manual vacuum aspiration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital Triage

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patient at the Women and Infants Triage/Women's Emergency Department
  • Vital signs are stable
  • Ages 18 and older
  • Have a missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy
  • Estimated gestational age up to 10 weeks
  • Undergoing MVA at the Women and Infants Triage/Women's Emergency Department
  • Able to read English or Spanish
  • Able to give informed consent for involvement in the study

Exclusion Criteria:

  • Allergic to lidocaine, iodine or betadine
  • Known sensitivity to any component of the lidocaine or placebo gel.
  • In acute distress
  • Unable to give informed consent
  • Unable to read English or Spanish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo gel
Placebo gel applied topically to the cervix
Drug: Placebo gel
odorless, colorless gel will be used as a placebo
Other Names:
  • KY Jelly
EXPERIMENTAL: Lidocaine gel
2% lidocaine gel applied topically to the cervix
Drug: Lidocaine
2% Lidocaine gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during intracervical block
Time Frame: immediate
Pain on visual analogue scale
immediate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during tenaculum placement
Time Frame: immediate
Pain on visual analogue scale
immediate
Pain during cervical dilation
Time Frame: immediate
Pain on visual analogue scale
immediate
Pain during uterine aspiration
Time Frame: immediate
Pain on visual analogue scale
immediate

Other Outcome Measures

Outcome Measure
Time Frame
Complications
Time Frame: 1 hour after procedure
1 hour after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bridgeport Hospital

Collaborators

Women and Infants Hospital of Rhode Island

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

October 11, 2012

First Submitted That Met QC Criteria

October 15, 2012

First Posted (ESTIMATE)

October 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-0039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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